Sekisui Diagnostics P.E.I., Inc. - FDA 510(k) Cleared Devices
6
Total
6
Cleared
0
Denied
Sekisui Diagnostics P.E.I., Inc. has 6 FDA 510(k) cleared medical devices. Based in Prince Edward Island, CA.
Last cleared in 2022. Active since 2011. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Sekisui Diagnostics P.E.I., Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Sekisui Diagnostics P.E.I., Inc.
6 devices
Cleared
Feb 18, 2022
Acetaminophen
Toxicology
525d
Cleared
Apr 17, 2019
SEKURE Creatine Kinase Assay
Chemistry
202d
Cleared
Feb 08, 2019
SEKURE Acetaminophen L3K Assay
Toxicology
315d
Cleared
Jul 12, 2018
SEKURE HbA1c Assay
Chemistry
283d
Cleared
Dec 08, 2016
DC-UIBC-CAL
Chemistry
35d
Cleared
Dec 02, 2011
MAGNESIUM ASSAY
Chemistry
149d